Tempus AI Enhances Cancer Research Tools With FDA-Cleared xR IVD

RNA sequencing provides a comprehensive view of biological information, offering deeper insights into disease mechanisms, including improved fusion detection. As a powerful tool in research and development, RNA analysis helps identify molecular pathways and networks directly involved in disease progression. Tempus AI TEM is leveraging this technology to advance therapeutic development through its Tempus xR IVD device, unlocking the full potential of RNA-based insights. Yesterday, the company received 510(k) clearance from the Food and Drug Administration (“FDA”) for its xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs. The Tempus xR IVD assay is a qualitative, next-generation sequencing–based in vitro diagnostic device that uses targeted, high-throughput, hybridization-based capture technology to detect rearrangements in two genes. It analyzes RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. Information provided by xR IVD is intended to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. The xR IVD device is one of several innovative solutions used by Tempus to drive advancements in oncology therapeutic research and development. Its FDA authorization reinforces Tempus’ position as a comprehensive, one-stop provider of precision medicine solutions.Peer UpdateAn expanding NGS oncology portfolio is helping Illumina ILMN drive the revolution in cancer genomics. The company’s market-leading TruSight Oncology assay, TSO 500, continues to see increased utilization and broader adoption. This year, Illumina is set to roll out TSO 500 v2, a new version that includes hundreds of genes across all variant classes and immuno-oncology biomarkers in a single assay from one sample, to facilitate therapy selection research. Following FDA approval last year, Illumina's in vitro diagnostic (IVD) TSO Comprehensive test has gained broad payer reimbursement, expanding access to comprehensive genomic profiling and enabling matching of patients with targeted therapies. QIAGEN QGEN sees significant opportunities for NGS to deliver on the vision of precision medicine. QIAGEN Digital Insights (“QDI”) business is extending its leadership by unlocking complex genomics data with greater speed and accuracy for clinical and research customers. The integration of AI into the QDI portfolio is another positive development. Recently, the company launched new QIAseq panels for use on next-generation sequencers, designed to enhance the analysis of over 700 genes for comprehensive genomic profiling in research and clinical applications. Additionally, the QIAseq xHYB CGP portfolio is being expanded to offer a highly curated solution for multimodal cancer genomic profiling. TEM Stock Outperforms Industry & BenchmarkIn the past year, Tempus AI shares have rallied 55.1%, outperforming the industry’s 22.7% growth and the S&P 500 composite’s 18.7% improvement.Image Source: Zacks Investment ResearchExpensive ValuationTEM currently trades at a forward 12-month Price-to-Sales (P/S) of 10.16X compared with the industry average of 5.59X.Image Source: Zacks Investment ResearchTEM Stock Estimate TrendIn the past 30 days, Tempus AI's loss per share estimate for 2025 has moved south 1 cent.Image Source: Zacks Investment ResearchTEM stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Zacks Names #1 Semiconductor StockThis under-the-radar company specializes in semiconductor products that titans like NVIDIA don't build. It's uniquely positioned to take advantage of the next growth stage of this market. And it's just beginning to enter the spotlight, which is exactly where you want to be.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $971 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Illumina, Inc. (ILMN): Free Stock Analysis Report QIAGEN N.V. (QGEN): Free Stock Analysis Report Tempus AI, Inc. (TEM): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks